Clinical Management With SPM System and Validation of the SPM 5 Hour Cutoff in Patients With Symptoms of Gastroparesis

Gastroparesis Clinical Trial

Official title:

Clinical Management With SmartPill Motility Monitoring System and Validation of the SmartPill Five Hour Cutoff in Patients With Symptoms of Gastroparesis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02022826
• Other study ID #: MA-501
• Status: Terminated
• Phase: N/A
• First received: December 15, 2013
• Last updated: November 1, 2017
• Start date: January 2014
• Est. completion date: March 2017

Study information

• Verified date: August 2017
• Source: Medtronic - MITG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This protocol is designed to validate use of the SPM for diagnosis of delayed gastric emptying in patients with symptoms of gastroparesis and assess impact of a SmartPill study on patient management in the gastroparetic populations. Patients with symptoms of gastroparesis will be recruited.

Patients will undergo concurrent gastric scintigraphy and SPM testing to determine the presence or absence of delayed gastric emptying based on predetermined diagnostic cutoffs for each technique.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 167
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Males and females between ages of 18-80 years of age with symptoms of gastroparesis for at least 12 weeks.

• Presenting with 2 or more of the following symptoms or signs which, in the opinion of the site investigator, are suggestive of a diagnosis of gastroparesis:

• 1 Nausea, vomiting, or retching (dry heaves)

• 2 Postprandial fullness or early satiety

• 3 Bloating or visible abdominal distention

• 4 Postprandial discomfort or pain

• Ability to stop proton pump inhibitors for 7 days and histamine2 receptor antagonists, prokinetic agents, narcotic agents, anticholinergic drugs, and cannabinoids 3 days prior to SPM and gastric scintigraphy testing.

• No evidence of metabolic disease (hypothyroidism, uncontrolled diabetes [hemoglobin A1c >10% within the past 6 months], electrolyte imbalance).

• An upper endoscopy or upper gastrointestinal barium series within the past 2 years showing no organic disease that is potentially causative of symptoms.

• High probability of compliance and completion of study.

Exclusion Criteria:

• Participation in previous SmartPill clinical trials.

• Previous history of bezoars (the presence of retained liquid, bile, or small amounts of poorly organized food residue is permitted).

• Dysphagia to solid food or pills.

• Prior surgery involving the luminal gastrointestinal tract (cholecystectomy, appendectomy, and hysterectomy are permitted if performed > 3 months prior to SPM test).

• Any abdominal or pelvic surgery within the past 3 months

• Known or history of inflammatory bowel disease.

• History of diverticulitis, diverticular stricture, and other intestinal strictures.

• Chronic daily use of nonsteroidal anti-inflammatory drugs (ibuprofen, naproxen, etc.)

• Tobacco or alcohol use within eight hours prior to capsule ingestion.

• BMI > 40 kg/m2.

• Allergies to eggs, bread, or jam.

• Females of childbearing age who are not practicing birth control and/or are pregnant or lactating. (Urine pregnancy testing will be performed on female subjects of child-bearing potential prior to capsule ingestion and gastric scintigraphy).

• Use of cardiac medical devices such as pacemakers and defibrillators (gastric stimulators, bladder stimulators, spinal stimulators, medication infusion devices, insulin pumps, continuous glucose monitors are permitted).

• Uncontrolled diabetes with a hemoglobin A1c >10%.

• Patient is expected to undergo MRI examination within 7 days after ingestion of the capsule

Related Conditions & MeSH terms

• Gastroparesis

Intervention

Device:
• SmartPill Monitoring System

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Georgia Regents University	Augusta	Georgia
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Fletcher Allen Health Care	Burlington	Vermont
United States	Clinsearch,LLC	Chattanooga	Tennessee
United States	Texas Tech University	El Paso	Texas
United States	Indiana University	Indianapolis	Indiana
United States	Florida Digestive Health	Largo	Florida
United States	Miami miller school of Medicin	Miami	Florida
United States	Stanford University	Palo Alto	California
United States	Temple University	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic - MITG

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Per Patient Device Agreement Between SmartPill Motility Monitoring System Gastric Emptying Time & Gastric Emptying Scintigraphy Test in Patients With Symptoms of Gastroparesis	Per patient device agreement for the diagnosis of delayed gastric emptying between SmartPill Motility Monitoring System (SPM) gastric emptying time (GET >5 hours) and the non-reference standard, gastric Emptying scintigraphy test (>10% retention of a solid meal at 4 hours) in patients with symptoms of gastroparesis	an expected average of two weeks from study procedure
Secondary	Agreement Between Gastric Emptying Time of SmartPill Capsule and Gastroduodenal Contractility and Percent of Radiolabeled Meal Retained at 4 Hours on Scintigraphy for Severe Gastroparesis	Agreement between Gastric emptying time of SmartPill capsule (GET>8hrs= severe) and gastroduodenal contractility and percent of radiolabeled meal retained at 4 hours on scintigraphy (>35% = severe)	an expected average of two weeks from study procedure